Health Canada approves Anthrasil® under Extraordinary Use New Drug Regulations
GAITHERSBURG, Md., Dec. 12, 2017 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has been awarded a contract by the Department of National Defence (DND) valued at approximately $8 million to deliver Anthrasil® (Anthrax Immune Globulin Intravenous [human]) to the Canadian government. This contract award follows the recent approval of Anthrasil by Health Canada under the Extraordinary Use New Drug (EUND) Regulations, which provide a regulatory pathway for products for which collecting clinical information for its intended use in humans is logistically or ethically not possible. Anthrasil is indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs.
“Receiving Health Canada approval of Anthrasil and being awarded the DND procurement contract reflect the Canadian government’s continued commitment to anthrax preparedness. Anthrax remains on the Canadian government’s list of top biological agents given its potential to be used in a bioterrorist attack,” said Dr. Laura Saward, senior vice president and antibody therapeutics business unit head at Emergent BioSolutions. “Emergent has a longstanding history and successful track record of partnering with governments to provide preparedness solutions in the form of critical medical countermeasures for these serious public health threats.”
Emergent received U.S. Food and Drug Administration approval for Anthrasil in 2015 and has delivered more than 10,000 doses of Anthrasil to the U.S. Strategic National Stockpile. It is the only polyclonal antibody therapeutic available in the U.S. and Canada for treating inhalational anthrax.
About Emergent BioSolutions
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally emerging public health threats. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025. Additional information about the company may be found at www.emergentbiosolutions.com. Follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates” and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including availability of funding for our Canadian and U.S. government grants and contracts and our manufacturing capabilities and strategy. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.
Robert G. Burrows
Vice President, Investor Relations
Vice President, Corporate Communications
Emergent Biosolutions, Inc.